Highly Purified Human Chorionic Gonadotropin In female Infertility

Phase 4

Completed

Conditions: Health Condition 1: null- Infertility

Registration Number: CTRI/2019/02/017770

Lead Sponsor: Bharat Serums and Vaccines Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

1. Subject undergoing ovulation induction with injectable gonadotropins with least 1 follicle >= 18 mm in size.

2. Subject aged >20 or <40 (Both inclusive)

3. BMI between 18 and 30 kg/m2.

4. Normogonadotrophic subjects with normal hormonal profile.

5. Male partner with semen parameters compatible with ART using ejaculated sperm.

6. Normal Uterine cavity and at least one normal tube confirmed on 3D US and Hystero Contrast Salpingogram (HycoSy) or hystosalpingogram (HSG) &/or Laparoscopy within 3 years before recruitment.

7. Transvaginal ultrasound documenting the presence of both ovaries, without evidence of abnormality (e.g. no endometrioma)and normal adnexa (e.g. no hydrosalphinx) within 6 months before recruitment.

8. Signed informed consent form before screening

Exclusion Criteria

1. Subject 20 or 40 years of age.

2. Infertility attributable to severe endometriosis (grade III or IV).

3. Subjects whose male partner needs surgical sperm retrieval.

4. Pelvic pathology that would compromise ART success.

5. Any chronic systemic disease including uncorrected hyperthyroid, hypothyroid hyperprolactinemia

6. Pregnancy, lactation or contraindication to pregnancy

7. Current or past ( last 12 months) abuse of alcohol and drugs.

8. Undiagnosed vaginal bleeding .

9. Tumors of the ovary, breast, adrenal gland, pituitary or hypothalamus and malformation of sexual organs incompatible with pregnacy.

10. Hypersensitivity to any trial product.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Serum hCG levels at 40 to 48 hours after administration of the HP-hCG injection. <br/ ><br>2. Progestterone level more than 1.2ng/ml on 40 to 48 hrs after HP-hCG administration. <br/ ><br>3. USG evidence of rupture of follicle.Timepoint: 40 to 48 hours

Secondary Outcome Measures